Anal leakage is a recognized medical problem and is widespread. A significant percentage of the adult population, both male and female, suffers from anal incontinence of one form or another. It has been described as “one of the most psychologically and socially debilitating conditions in an otherwise healthy individual” (Seymour, Stephen D., “Fecal Incontinence”, emedicine, Dec. 3, 2002).
Anal incontinence, also called fecal incontinence, is the loss of anal sphincter control leading to unwanted or untimely release of feces. It can range from total incontinence to very minor, where the patient may pass only small amounts of flatus or mucous. Minor anal incontinence generally causes embarrassing soiling. In addition to incontinence, such soiling can also result from hemorrhoids, fistulae, or the application of topical medicaments. There is a wide spread in reported incidence, but it is generally agreed that over 2% of the general adult population suffers from some degree of anal incontinence. The condition is actually probably underreported: only 30% of people with anal incontinence have spoken about it with their physician and only about 5% had it noted on their medical charts. It is not a topic that is generally discussed and is consequently often considered shameful.
It has been estimated that $400 million is spent on adult diapers each year. In the United States, if the generally reported 2% incidence is accepted, there are 6 million anal incontinents. This figure is probably far lower than actual, and does not include the hemorrhoid population, which is about 5% of the general population, or about 15 million.
It is further estimated that between 15 and 35% of patients with anal fistulae have post-operative incontinence, depending to some extent upon the procedure used. The incidence is 8.6 cases per 100,000 population: in men, the incidence is 12.3 cases per 100,000 population, and in women, the incidence is 5.6 cases per 100,000 population. Of women with multiple births, about 26% have some form of post partum anal incontinence and 30% of women over the age of 65 have anal incontinence to some degree, often associated with urinary incontinence. The incidence in males increases in the over-50 age group. Incontinence increases with advancing age, and as our population ages the need for protection will increase. Incontinence products are currently the fastest-growing items of the personal absorbent market.
Current practical solutions to the problem exist in the form of absorbent undergarments such as diaper-like devices, or waterproof pants with absorbent liners. These are generally designed primarily for urinary incontinence and, because of anatomical considerations, are most successful in females. They are generally bulky, uncomfortable, and difficult for the wearer to conceal.
Many individuals suffer from anal leakage of less severe form than total fecal incontinence. This problem generally ranges from mild leakage of mucous to occasional, intermittent leaks of small amounts of feces. Additionally, there are some disorders, such as hemorrhoids, where it is particularly difficult to clean the affected area after defecation, a situation that creates the possibility of soiling one's undergarments. There are some items designed to deal with fecal incontinence or uncontrollable diarrhea. Some of these have cup-shaped reservoirs, or are diaper-like underpants.
Minor anal incontinence, such as loss of mucous or minor fecal leakage, does not warrant the bulk and inconvenience of the incontinence undergarments currently on the market. Thinner absorbents, such as pantyliners, can potentially provide protection against staining and may be readily worn without being visible. However, current pantyliners and other external absorbent catamenial products are designed for the female anatomy, being specifically designed to cover the vaginal area. As such, they are not particularly well suited to covering the anal region. Successful coverage of this area requires special design.
As mentioned, there are adult “diaper”-like absorbents, and for the lighter cases, there are women's pantyliners. None are satisfactory for minor incontinence. All diaper-like products are bulky, relatively expensive, and uncomfortable. The pantyliner and absorbent pad, designed for catamenial purposes, bunches up in the crotch area and fails to cover the anal region adequately, often resulting in leakage, staining, and discomfort. Most absorbent articles meant to be worn beneath undergarments are intended for use to control menstrual discharge, vaginal exudates in women or urethral incontinence in either sex. Absorbent articles designed for men are generally those dealing with urinary incontinence such as post-surgical incontinence. Disposable panties also exist, some with pantyliner-like padding in the genital and anal areas, but these are typically not secure over the anal region, as well as being rather indiscreet with respect to the wearer's problem.
Physical exercise, such as athletic activity or physical labor, can also result in profuse sweating that will also leak through, and stain undergarments and outerwear. The volume of such leakage can be readily accommodated by the absorbent materials currently employed in the vaginal-oriented pantyliners designed specifically for females. However, the pantyliners currently available are designed to absorb menstrual flow or vaginal secretions. As such, they are products that speak to female discharge and therefore address specifically the female anatomy. These designs are generally in the “hour-glass” shape (for example, U.S. Pat. No. 6,436,080) or rectangular, with or without rounded edges (for example, U.S. Pat. Pub. No. 2002/0087132A1). A few designs are more complex, and are designed for wear by women with thongs or “G” strings (for example, U.S. Pat. No. 6,350,258 and U.S. Pat. No. 5,713,886). While many of these items have a tapered shape, they are specifically constructed for covering, and absorbing leakage from, the vaginal area, while generally leaving the anal region completely exposed, thus making them obviously unsuitable for use in absorbing discharge from the anal region.
The design of current pantyliners therefore does not make them comfortable to wear, nor particularly suited to either sex, for the control of anal discharge. Although they may function well when used on the female anatomy to control vaginal discharge or urethral incontinence, they are of inappropriate shape, thickness, and size to effectively contain anal leakage in either the male or female. In particular, the typical hourglass shaped pantyliner, when worn to contain anal exudates, has one wide end of the device crimped into the crotch, where it chafes, particularly (in the male) the posterior scrotum. It is uncomfortable and, since it does not conform to the body, may permit leakage. The narrow middle portion is not wide enough to guarantee bridging the inter-buttock cleft and the other wide portion of the hourglass liner is not wide enough to cover the anal region with confidence. Further, normal lateral shifting of the undergarment may displace it enough to permit leakage.
A prior art anal incontinence product is disclosed in U.S. Pat. No. 4,681,577 (Stem et al). It appears that the purpose of the product of Stem et al is to contain large volumes of feces and urine in a device for the totally incontinent female. The device of Stem et al is essentially a semirigid boat-shaped container, from 0.25 to 2 inches deep, filled with absorbent material in a particular manner. The front portion of the Stem et al device is specifically designed to collect urine and will not work for males where the external genitalia will get in the way and prevent close body contact.
In short, no current product deals successfully with light anal leakage or offers suitable, comfortable protection from anal soiling, whatever the etiology. Devices designed to accommodate severe fecal incontinence are too bulky and uncomfortable to wear when only a lesser problem exists. What has been needed, therefore, is an absorbent pantyliner that is specifically designed to absorb minor leakage or other soiling from the anal area, that stays secure during sports and other activities, and that is comfortable and secure for males as well as females.